Viatris, Cipla and Aurobindo sign up to make generics of GSK's long-acting HIV PrEP drug

In an effort to bolster drug access in dozens of countries around the globe, three generics makers have obtained sublicenses to make low-cost versions of GSK’s long-acting HIV PrEP drug Apretude.

Under a licensing deal signed with GSK’s ViiV Healthcare last year, the United Nations-backed Medicines Patent Pool (MPP) has granted Aurobindo, Cipla and Viatris rights to make generic versions of Apretude, or cabotegravir long-acting, for 90 low- and middle-income countries.

All three generic companies will make their copycat versions in India. Cipla also has plans to manufacture the medicine from South Africa.

ViiV will work together with MPP and help the three generic companies proceed with development, manufacturing and supply, ViiV’s CEO Deborah Waterhouse said in a statement.

The MPP selected the three firms after a blinded assessment and an on-site technical review of their experience, manufacturing capacity and equipment readiness to produce long-acting nano-suspension-based injectables in “the shortest possible time,” according to ViiV.

As MPP’s executive director Charles Gore noted in a statement, the Apretude agreements are the first the organization has signed for a long-acting medicine.

Still, it might take some time before a generic Apretude can be made available to people in those countries. Under a prior licensing deal between GSK, MPP and Aurobindo, it took about three years for the first generic version of GSK’s oral HIV treatment Tivicay to receive a regulatory approval, a ViiV spokesperson noted in an email to Fierce Pharma.

Apretude is a more complex product, so the timeline might be extended this time around, the spokesperson said. Before the copycats are commercially available, GSK has committed to make Apretude available at nonprofit prices for public programs in low-income countries.

For now, the three companies have established some plans about the initial capacity they will set aside. The exact level of demand for Apretude remains unclear right now, ViiV’s spokesperson said.

Neither ViiV nor MPP has control over the generics’ final prices or the countries they’ll supply first. But, as the ViiV spokesperson explained, “[e]nabling up to three generics allows for competition but avoids a fractured market with too many manufacturers.”

Apretude is currently approved to prevent HIV in at-risk people in the U.S., Australia, Zimbabwe, South Africa and Malawi. In the U.S., the drug is given every two months during the maintenance phase. In two phase 3 trials, Apretude showed superior efficacy versus Gilead Sciences’ off-patent daily oral drug Truvada in preventing HIV infections.

GSK launched Apretude last year as the world’s first long-acting injectable for PrEP and quickly signed off on a patent license to MPP. The rollout came as Truvada lost its patent protection and as Gilead worked to switch PrEP users to its newer Descovy, which has a better toxicity profile. Both daily drugs face a compliance problem, and GSK hopes its long-acting Apretude can help users stay up to date with their needed doses.

Last year, GSK mostly focused its launch efforts on securing payer access and setting up the process for doctors to administer the drug, Waterhouse told Fierce Pharma in an interview in February. As the groundwork was being laid, Apretude generated 41 million pounds sterling ($50 million) in 2022.

In 2023, GSK is “expecting to see material sales,” she said, given the strong underlying demand. But, as Waterhouse noted, the overall PrEP market, though growing fast, is much smaller than the HIV treatment field.